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FDA ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits

蒋千琴 10/15/2021 浏览 148 FDA 美国

标准简介

ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits[附网盘链接]是于不久之前发布的FDA标准，适用于美国。

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ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits[附网盘链接]
ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits[附网盘链接](截图)

 

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ANDA Submissions – Refuse to Receive for Lack of Justification of Impurity Limits 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to assist applicants preparing to submit to the Food and Drug Administration (FDA) original abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of 2

the drug product. The guidance highlights deficiencies in relation to information about 3,4

impurities that may cause FDA to refuse to receive (RTR) an ANDA. An RTR decision indicates that FDA determined that an ANDA is not sufficiently complete to permit a substantive 5

review. Typical deficiencies leading to an RTR decision include: (1) failing to provide justification for proposed limits in drug substances and drug products for specified identified impurities that are above qualification thresholds; (2) failing to provide justification for proposed limits for specified unidentified impurities that are above identification thresholds; and (3) proposing limits for unspecified impurities (e.g., any unknown impurity) that are above identification thresholds. This guidance is not meant to be a comprehensive list of deficiencies in relation to impurity information that may or will lead FDA to make an RTR determination. Rather, this guidance clarifies that a failure to provide justification for proposed impurity limits may lead FDA to RTR 1

This guidance has been prepared by the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. 2

For purposes of this guidance, the use of the term ANDA will mean ANDAs and new-strength PAS submissions. 3

This should not be confused with a refuse-to-approve determination. 4

The following types of products are currently excluded from this guidance: (1) biological/biotechnologicals; (2) peptides; (3) oligonucleotides; (4) radiopharmaceuticals; (5) fermentation products; (6) semisynthetic products derived from fermentation products; (7) herbal products; (8) crude products of animal or plant origin; and (9) enantiomeric impurities. For additional information on the applicability to ANDAs, see guidances for industry ANDAs: Impurities in Drug Substances; ANDAs: Impurities in Drug Products; See also, guidances for industry Q3A(R) Impurities in New Drug Substances (Q3A(R)); and Q3B(R2) Impurities in New Drug Products (Q3B(R2)). 5

21 CFR 314.101(b)(1).

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